I sent Drug Listings through eList more than a month ago. I am not seeing my NDCs reflected in the NDC Directory. What do I do?
Answer
Sample Letter Text:
Extract from a note to FDA [eDRLS@fda.hhs.gov]:
...
It has come to my attention the FDA NDC Directory does not have SPONSOR data loaded correctly into the FDA NDC Directory database. All of the SPONSOR Legal Firm Names are incorrect and do not match what has been submitted electronically to the FDA eList system. Not all SPONSOR eListed prescription products are appearing on the NDC Directory as the products have been eListed and accepted by the FDA eList system prior to November 30, 2009 (date indicated on FDA website of last update).
....
To rectify this, the SPONSOR sent -- among other things -- a list of the NDC codes missing or with errors, the date those codes were submitted, along with CoreID of submission as additional proof. Some of the NDCs had been submitted via eList during the summer, and still had not been updated in the directory.
Extract from e-mail:
CoreId: 123456789.111111@llnap01_te
DateTime Receipt Generated: 07-17-2009, 09:46:25
The following PRODUCT NDCs were submitted on DATE:
Table containing product name, dose, quantity; ndc code; application # followed
Reference(s) :
(Include link to authoritative source(s) when available)
[11-Dec-2009]
Subject:
Missing Entries in NDC DirectoryQuestion:
I sent Drug Listings through eList more than a month ago. I am not seeing my NDCs reflected in the NDC Directory. What do I do?Answer
Sample Letter Text:
Extract from a note to FDA [eDRLS@fda.hhs.gov]:...
It has come to my attention the FDA NDC Directory does not have SPONSOR data loaded correctly into the FDA NDC Directory database. All of the SPONSOR Legal Firm Names are incorrect and do not match what has been submitted electronically to the FDA eList system. Not all SPONSOR eListed prescription products are appearing on the NDC Directory as the products have been eListed and accepted by the FDA eList system prior to November 30, 2009 (date indicated on FDA website of last update).
....
To rectify this, the SPONSOR sent -- among other things -- a list of the NDC codes missing or with errors, the date those codes were submitted, along with CoreID of submission as additional proof. Some of the NDCs had been submitted via eList during the summer, and still had not been updated in the directory.
Extract from e-mail:
CoreId: 123456789.111111@llnap01_te
DateTime Receipt Generated: 07-17-2009, 09:46:25
The following PRODUCT NDCs were submitted on DATE:
Table containing product name, dose, quantity; ndc code; application # followed
Reference(s) :
(Include link to authoritative source(s) when available)